NCT00154102 · OUTCOME

Overall Survival Time (KRAS Mutant Population)

Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) · Source last updated 2017-01-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009

What was measured

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.

Analysis population: Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009

Groups in this outcome

Cetuximab Plus FOLFIRI

Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops

FOLFIRI Alone

Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Cetuximab Plus FOLFIRI	214
FOLFIRI Alone	183

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Cetuximab Plus FOLFIRI	16.2	Not reported	14.9	17.9	Not reported
FOLFIRI Alone	16.7	Not reported	14.9	19.4	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.834
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.284
group Description
The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.7549
param Type
Hazard Ratio (HR)
param Value
1.035
statistical Comment
Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
statistical Method
Stratified log rank
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.834
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.284
group Description
The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.7549
param Type
Hazard Ratio (HR)
param Value
1.035
statistical Comment
Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.
statistical Method
Stratified log rank
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
14.9
upper Limit
17.9
value
16.2
group Id
OG001
lower Limit
14.9
upper Limit
19.4
value
16.7

denoms

counts
group Id
OG000
value
214
group Id
OG001
value
183
units
Participants

description

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.

dispersion Type

95% Confidence Interval

groups

description
Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
id
OG000
title
Cetuximab Plus FOLFIRI
description
Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops
id
OG001
title
FOLFIRI Alone

param Type

MEDIAN

population Description

Intent to Treat (ITT) population with KRAS Mutant tumor status as collected until 28 August 2009

reporting Status

POSTED

time Frame

Time from randomisation to death or last day known to be alive reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009

title

Overall Survival Time (KRAS Mutant Population)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Independent clinical review pending · Not medical advice